Reform HA Coated Pedicle Screw System 39-BK-0601

GUDID 00840019936200

Implant Kit

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00840019936200
• NIH Device Record Key: 8ef9621f-1d9a-4c4f-ad84-94c338e0b90d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform HA Coated Pedicle Screw System
• Version Model Number: 39-BK-0601
• Catalog Number: 39-BK-0601
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019936200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151422

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-27
• Device Publish Date: 2019-08-19

On-Brand Devices [Reform HA Coated Pedicle Screw System]

• 00815362020500: 9.5 x 100mm Reform HA Coated Pedicle Screw System
• 00815362020630: 10.5 x 120mm Reform HA Coated Pedicle Screw System
• 00815362020623: 10.5 x 110mm Reform HA Coated Pedicle Screw System
• 00815362020616: 10.5 x 100mm Reform HA Coated Pedicle Screw System
• 00815362020609: 10.5 x 90mm Reform HA Coated Pedicle Screw System
• 00815362020593: 10.5 x 80mm Reform HA Coated Pedicle Screw System
• 00815362020586: 10.5 x 70mm Reform HA Coated Pedicle Screw System
• 00815362020579: 10.5 x 60mm Reform HA Coated Pedicle Screw System
• 00815362020562: 10.5 x 55mm Reform HA Coated Pedicle Screw System
• 00815362020555: 10.5 x 50mm Reform HA Coated Pedicle Screw System
• 00815362020548: 10.5 x 45mm Reform HA Coated Pedicle Screw System
• 00815362020531: 10.5 x 40mm Reform HA Coated Pedicle Screw System
• 00815362020524: 9.5 x 120mm Reform HA Coated Pedicle Screw System
• 00815362020517: 9.5 x 110mm Reform HA Coated Pedicle Screw System
• 00815362020494: 9.5 x 90mm Reform HA Coated Pedicle Screw System
• 00815362020487: 9.5 x 80mm Reform HA Coated Pedicle Screw System
• 00815362020470: 9.5 x 70mm Reform HA Coated Pedicle Screw System
• 00815362020463: 9.5 x 60mm Reform HA Coated Pedicle Screw System
• 00815362020456: 9.5 x 55mm Reform HA Coated Pedicle Screw System
• 00815362020449: 9.5 x 50mm Reform HA Coated Pedicle Screw System
• 00815362020432: 9.5 x 45mm Reform HA Coated Pedicle Screw System
• 00815362020425: 9.5 x 40mm Reform HA Coated Pedicle Screw System
• 00815362020418: 8.5 x 120mm Reform HA Coated Pedicle Screw System
• 00815362020401: 8.5 x 110mm Reform HA Coated Pedicle Screw System
• 00815362020395: 8.5 x 100mm Reform HA Coated Pedicle Screw System
• 00815362020388: 8.5 x 90mm Reform HA Coated Pedicle Screw System
• 00815362020371: 8.5 x 60mm Reform HA Coated Pedicle Screw System
• 00815362020364: 8.5 x 60mm Reform HA Coated Pedicle Screw System
• 00815362020357: 8.5 x 60mm Reform HA Coated Pedicle Screw System
• 00815362020340: 8.5 x 55mm Reform HA Coated Pedicle Screw System
• 00815362020333: 8.5 x 50mm Reform HA Coated Pedicle Screw System
• 00815362020319: 8.5 x 40mm Reform HA Coated Pedicle Screw System
• 00815362020302: 8.5 x 35mm Reform HA Coated Pedicle Screw System
• 00815362020296: 7.5 x 80mm Reform HA Coated Pedicle Screw System
• 00815362020289: 7.5 x 70mm Reform HA Coated Pedicle Screw System
• 00815362020272: 7.5 x 60mm Reform HA Coated Pedicle Screw System
• 00815362020265: 7.5 x 55mm Reform HA Coated Pedicle Screw System
• 00815362020258: 7.5 x 50mm Reform HA Coated Pedicle Screw System
• 00815362020241: 7.5 x 45mm Reform HA Coated Pedicle Screw System
• 00815362020234: 7.5 x 40mm Reform HA Coated Pedicle Screw System
• 00815362020227: 7.5 x 35mm Reform HA Coated Pedicle Screw System
• 00815362020210: 7.5 x 30mm Reform HA Coated Pedicle Screw System
• 00815362020203: 6.5 x 60mm Reform HA Coated Pedicle Screw System
• 00815362020197: 6.5 x 55mm Reform HA Coated Pedicle Screw System
• 00815362020180: 6.5 x 50mm Reform HA Coated Pedicle Screw System
• 00815362020173: 6.5 x 45mm Reform HA Coated Pedicle Screw System
• 00815362020166: 6.5 x 40mm Reform HA Coated Pedicle Screw System
• 00815362020159: 6.5 x 35mm Reform HA Coated Pedicle Screw System
• 00815362020142: 6.5 x 30mm Reform HA Coated Pedicle Screw System
• 00815362020135: 6.5 x 25mm Reform HA Coated Pedicle Screw System